UMIN-CTR Clinical Trial

Basic information
Public title	Japanese study of the effects of vascular access closure on the kidney function in kidney transplant recipients.
Acronym	JACKTR-Study
Scientific Title	Japanese study of the effects of vascular access closure on the kidney function in kidney transplant recipients.
Scientific Title:Acronym	JACKTR-Study
Region	Japan

Condition
Condition	chronic renal failure
Classification by specialty	Nephrology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation for the effects of vascular access closure on the kidney function in kidney transplant recipients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	renal function
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	from 2000.9 to 2020.9 stable out patient (renal transplant rescipients) post operation of vascular access closure (more than 2 years)
Key exclusion criteria	1.uncontrol malignant disease. 2.chronic inflammatory disease 3.chronic infectious disease 4.Child-Pugh Grade C liver cirrhosis
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Toshihide Middle name Last name Naganuma
Organization	Osaka City University
Division name	Department of Urology
Zip code	545-8586
Address	1-4-3 asahi-machi, abenno-ku, Osaka Cuty
TEL	06-6645-3857
Email	spxd48k9@aria.ocn.ne.jp

Public contact
Name of contact person	1st name Toshihide Middle name Last name Naganuma
Organization	Osaka City University
Division name	Department of Urology
Zip code	545-8586
Address	1-4-3 asahi-machi, abenno-ku, Osaka Cuty
TEL	06-6645-3857
Homepage URL
Email	spxd48k9@aria.ocn.ne.jp

Sponsor
Institute	Osaka City University
Institute
Department

Funding Source
Organization	Japanese Society for Clinical Renal Transplantation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Department of Urology, Osaka City University
Address	1-4-3 asahi-machi, abeno-ku, Osaka Cuty
Tel	06-6645-3857
Email	spxd48k9@aria.ocn.ne.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪市立大学医学部附属病院、北里大学医学部附属病院、長崎大学医学部附属病院、奈良県立大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2020 Year 10 Month 14 Day
Date of IRB	2020 Year 10 Month 14 Day
Anticipated trial start date	2020 Year 10 Month 14 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	with RED-Cap system

Management information
Registered date	2020 Year 12 Month 22 Day
Last modified on	2021 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048875